UMIN-CTR Clinical Trial

Basic information
Public title	Glycemic variability from switching to steady state in patients treated with long-acting insulin: randomised crossover study
Acronym	Glycemic variability from switching to steady state in patients treated with long-acting insulin
Scientific Title	Glycemic variability from switching to steady state in patients treated with long-acting insulin: randomised crossover study
Scientific Title:Acronym	Glycemic variability from switching to steady state in patients treated with long-acting insulin
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the glycemic variability from switching to steady state in patients treated with long-acting insulin (insulin glargine 300 U/ml, next, insulin degludec or insulin degludec, next, insulin glargine 300 U/ml).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean of daily difference 1 (MODD1)
Key secondary outcomes	Multiple continuous overlapping net glycemic action 24 (MCONGA24) (original index) Standard deviation of daily difference (SDODD) (original index) Mean of daily difference (MODD) (day before switching vs. first day, second day vs. third day, fifth day vs. sixth day) continuous overlapping net glycemic action 24 (CONGA24) (day before switching vs. first day, second day vs. third day, fifth day vs. sixth day) Mean absolute glucose (MAG) during evaluation duration (for 7 days) Glycemic variability percentage (GVP) during evaluation duration (for 7 days) Mean glucose level during evaluation duration (for 7 days) Standard deviation (SD) during evaluation duration (for 7 days) Coefficient of variation (CV) during evaluation duration (for 7 days) We investigated the relationship between glycemic diurnal variation (MAG, GVP, mean glucose level, and SD) and glycemic daily variation (MODD and CONGA24) using simulated CGM profiles measured every 15 minute for 24 hours.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Upon admission, insulin glargine 300 U/ml is continued for 6 days with the same dose. FreeStyle Libre Pro is worn on fifth day of the same dose insulin glargine 300 U/ml. Insulin glargine 300 U/ml is switched to insulin degludec on day 3 of wearing CGM device with the same dose and is continued for 6 days. Then, Insulin degludec is switched to insulin glargine 300 U/ml on day 9 with the same dose and is continued for 6 days. Evaluation duration are from day 2 to day 8 and from day 8 to day 14.
Interventions/Control_2	Upon admission, insulin degludec is continued for 6 days with the same dose. FreeStyle Libre Pro is worn on fifth day of the same dose insulin degludec. Insulin degludec is switched to insulin glargine 300 U/ml on day 3 of wearing CGM device with the same dose and is continued for 6 days. Then, Insulin glargine 300 U/ml is switched to insulin degludec on day 9 with the same dose and is continued for 6 days. Evaluation duration are from day 2 to day 8 and from day 8 to day 14.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	type 2 diabetic patients treated with long-acting insulin in basal insulin therapy for 3 month or longer
Key exclusion criteria	severe renal dysfunction (serum creatinine level over 2.0 mg/dL) judged to be unsuitable for participation for medical reasons
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Soichi Takeishi
Organization	Inuyama Chuo General Hospital
Division name	Diabetes
Zip code
Address	6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL	0568-62-8111
Email	souichi19811225@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Soichi Takeishi
Organization	Inuyama Chuo General Hospital
Division name	Diabetes
Zip code
Address	6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL	0568-62-8111
Homepage URL
Email	souichi19811225@yahoo.co.jp

Sponsor
Institute	Inuyama Chuo General Hospital
Institute
Department

Funding Source
Organization	Inuyama Chuo General Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 04 Day
Last modified on	2020 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037467